Registration Dossier
Registration Dossier
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EC number: 256-367-4 | CAS number: 49553-76-6
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment for Oleic acid, monoester with oxybis(propandiol) (CAS 49553-76-6) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2008).
Persistence
Oleic acid, monoester with oxybis(propandiol) (CAS 49553-76-6) is readily biodegradable based on one study according to OECD 301B (78% after 21 d; CO2 evolution). Thus, the test substance does not meet the screening criterion for persistency and it is not considered to be persistent (P) or very persistent (vP).
Bioaccumulation
Oleic acid, monoester with oxybis(propandiol) (CAS 49553-76-6) indicates a low bioaccumulation potential in organisms based on estimated BCF value (BCF: 80.9 L/kg, regression based) using BCFBAF v3.01. When including biotransformation rate constants a BCF and a BAF of 17.03 L/kg resulted (Arnot-Gobas estimate, including biotransformation, upper trophic). In conclusion, Oleic acid, monoester with oxybis(propandiol) has a low potential for bioaccumulation, as the highest calculated BCF of 80.9 L/kg is clearly below the trigger value of 2000 L/kg according to PBT-criteria (ECHA Guidance R.11, 2008). Thus, the test substance is not considered to be bioaccumulative (B) or very bioaccumulative (vB).
Toxicity
Long term toxicity values are available for Daphnia magna (NOEC (21d) = 1.85 mg/L) for the read-across substance 2,3-dihydroxypropyl oleate (in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5) and Pseudokirchneriella subcapitata (NOEC (72 h) = 0.0113 mg/L), both above the trigger value of 0.01 mg/L. Thus, the criteria set out in Annex XIII of Regulation (EC) No 1907/2006 are not met and the test substance is not considered to meet the T criterion.
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